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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA TW 8MM BLS 400 SG; SYRINGE, ANTISTICK

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BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA TW 8MM BLS 400 SG; SYRINGE, ANTISTICK Back to Search Results
Catalog Number 305937
Device Problem Failure to Deliver (2338)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/15/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that syringe 0.3ml 31ga tw 8mm bls 400 sg was unable to deliver medication.This was discovered during use.The following information was provided by the initial reporter: obstruction.Can¿t extract medicine.
 
Event Description
It was reported that syringe 0.3ml 31ga tw 8mm bls 400 sg was unable to deliver medication.This was discovered during use.The following information was provided by the initial reporter: obstruction.Can¿t extract medicine.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 6/30/2020.H.6.Investigation: customer returned (1) 3/10cc, 8mm, 31g bd safetygglide insulin syringe in an open blister pack from lot # 8325571.Customer states that there is an obstruction and they can¿t extract the medicine.The returned syringe was tested and was not able to draw properly.The sample was then wired and the wire was not able to pass through the cannula, indicating that there is an adhesive clog in the cannula.A review of the device history record was completed for batch# 8325571.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [200791593, 200791313] noted that did not pertain to the complaint.Process: the racks carrying the hub with cannula move further down along a rail, a pullout device moves the cannula out a small distance for adhesive to be applied.During the parts pass under the corona treater pins and exposed to an ion rich corona field, which increases surface energy wettability to aid in the adhesion of the adhesive to the hub.The cannula is then re-inserted into the hub with vacuum.The pim inspection systems looks for adhesive clogs and rejects the needle assemblies in the process.Investigation: a review of the device history record was completed for batch# 8325571.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [200791593, 200791313] noted that did not pertain to the complaint.Root cause: root cause cannot be determined for this complaint.
 
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Brand Name
SYRINGE 0.3ML 31GA TW 8MM BLS 400 SG
Type of Device
SYRINGE, ANTISTICK
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key10209737
MDR Text Key198081779
Report Number1920898-2020-00764
Device Sequence Number1
Product Code MEG
Combination Product (y/n)N
PMA/PMN Number
K992734
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 07/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/30/2023
Device Catalogue Number305937
Device Lot Number8325571
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/30/2020
Initial Date Manufacturer Received 06/09/2020
Initial Date FDA Received06/29/2020
Supplement Dates Manufacturer Received06/09/2020
Supplement Dates FDA Received07/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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